RE:RE:RE:Technical analysisTheir timelines are controlled by the FDA. FDA does not understand biofilms, so they keep wasting time asking questions. No one can tell when the FDA will make decisions, and you can't just call them up with info or to ask the FDA for advice. Pre-submission communication with the FDA is only done by appointment and they are booked up for months. One company that I was invested in said during the approval process, the FDA would occasionally ask them the same question that they had asked in a previous meeting, and which the company had answered. It's a frustrating process, but shareholders want timelines, so KNE came up with estimates.